Clinical Study of the Safety of a Single-port Endoscopic Surgical System for General Surgery

Shanghai Jiao Tong University

Status: Enrolling

Conditions: General Surgery

Treatments: Procedure: Robotic assisted single-port general surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05486299

RASIS-01

Details and patient eligibility

About

This is a small-scale pre-clinical exploratory study to investigate the safety of a novel single-port robotic system for general surgery.

Full description

Single-incision laparoscopic surgery is a surgical procedure in which multiple laparoscopic instruments are placed through a single small incision. It has the advantages of less surgical trauma, better cosmetic results and less postoperative pain compared with conventional laparoscopic surgery. However, the technical challenges and difficulties, including loss of triangulation, parallel coaxial effect, difficulty of achieving correct exposure, shared fulcrum, lack of ergonomic favorable position, etc. limited its widespread use. Robot-assisted laparoscopic surgery have significant advantages such as minimally invasive, delicate, and flexible, which can greatly expand the surgeon's surgical capabilities and effectively solve the various problems faced by traditional surgery. Therefore, robotic assisted single-port surgery is attracting increasing attention. This study is to investigate the safety of a novel single-port robotic system for general surgery.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years < age ≤75 years
• Suitable for minimally invasive surgery
• 18.5≤BMI≤28 kg/m2
• ASA score is Ⅰ-Ⅲ
• Informed consent
• Colon and rectal resection: colon and rectal polyps, inflammatory bowel disease, intestinal diverticula, colorectal cancer diagnosed cT3N0M0 with a maximum diameter of ≤4 cm located above the peritoneal reflection.
• Partial gastrectomy: gastric stromal tumor, gastric giant ulcer.
• Appendectomy: chronic appendicitis.
• Cholecystectomy: chronic cholecystitis combined with gallbladder stones, gallbladder polyps (> 1 cm).

Exclusion criteria

• With other malignancies or a previous history of other malignancies
• Undergone other major surgical treatment within 3 months prior to enrolment or planned during the trial
• With active tuberculosis
• With severe systemic disease
• With long-term use of anticoagulant and anti-platelet drugs (anti-platelet aggregation drugs discontinued less than 1 week prior to surgery), history of bleeding disorders or hematopoietic or coagulation disorders.
• With severe allergies and suspected or established alcohol, drug or substance addiction
• Patients who are immunodeficiency virus (HIV) antibody positive; hepatitis B surface antigen (HbsAg) positive and have a hepatitis B virus DNA (HBV-DNA) copy number above the lower limit of detection or normal range; hepatitis C virus (HCV) antibody positive; syphilis spirochete antibody positive and at high risk of transmission as judged by the investigator.
• Emergency surgery
• Women who are pregnant, breastfeeding or planning to become pregnant during the trial
• Other conditions which, in the opinion of the investigator, make participation in this trial inappropriate.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Single-port Endoscopic Surgical System

Experimental group

Description:

A novel robotic surgical system that can be configured for multi-port, single-port, or hybrid-port procedures. In the single-port configuration, a four-channel trocar shall be used. The surgical tools are steered through the curved access channels in the trocar to enter a patient's abdomen.

Treatment:

Procedure: Robotic assisted single-port general surgery